Osteoarthritis, posttraumatic arthritis, inflammatory arthritis such as rheumatoid arthritis, systemic lupus erythematosus and ankylosing spondylitis, and degenerative joint disease are all common musculoskeletal disorders that cause wear and tear on a joint. In particular, protective cartilage which cushions the bones at the joint can break down and wear away over time. When this happens, the bones rub against each other, causing pain, swelling, stiffness, and restricted movement. While osteoarthritis and other musculoskeletal disorders damage the joint, they also harm the muscles, tendons, ligaments, cartilage, nerves, and discs.
Musculoskeletal diseases can affect any person of any age, and in many cases no cure exists. But several forms of treatment can slow the progression and severity of musculoskeletal joint, limb, or spine disorders involving the bones, cartilage, tendons, ligaments, muscles, nerves, or discs, as well as relieve pain and improve joint function. One typical form of treatment of arthritis and musculoskeletal soft tissue diseases involves bracing the joint—or an area near the joint—with an orthotic device. Orthotic devices, such as a knee brace, are known to provide unloading support and strength to an injured joint. Despite providing some therapeutic benefits, knee braces are known to cause muscle atrophy as a result of immobilizing the joint. As a means to prevent this negative effect, muscle stimulating means are combined with orthotic devices and other similar devices to assist in either inhibiting or preventing harmful deterioration of muscle mass. Furthermore, an orthotic device or other rehab device with stimulating means can control pain in the muscles and rehabilitate the injured joint and soft tissues without requiring physical penetration through the skin. As an example, this advantage is particularly important to patients with knee osteoarthritis who do not wish for an invasive surgical procedure or a total knee replacement, or patients who have medical contraindications to knee replacement. Therefore, orthotic devices that can simultaneously provide transcutaneous stimulation, unloading support for weight-bearing joints, and other mechanical therapeutic benefits to any joint in general offer an attractive option for alleviating pain and facilitating the rehabilitation of arthritic joints and muscles.
Some orthotic devices use electrical currents as a form of stimulation to reduce pain and aid in muscle therapy. For example, U.S. Pat. No. 5,947,913 to Palumbo discloses a patellar stabilizing brace comprising a bracing means for applying a medial force on the patella, a generator producing neuromuscular electrical stimulation (NES), and a plurality of electrodes to transmit the electrical stimulation to a muscle mass. The generator is mounted on a sleeve that attaches to the brace using hook-and-loop VELCRO® fasteners while the electrodes are disposed along the sleeve, either penetrating it or passing beneath or above it. Thus, a patient wearing the stabilizing brace would experience periodic stimulation from the electrodes via a transcutaneous method. Further, a transcutaneous electrical nerve stimulation (TENS) unit for providing pain management can be attached to the stabilizing brace. However, without a controller, the Palumbo device lacked the capability for selectively stimulating certain muscles or implementing a programmed sequence of stimulation.
Other efforts have been made to provide an orthotic device conveying some form of stimulation to aid in the therapy of osteoarthritis. For example, U.S. Pat. No. 7,783,348 to Gill et al. discloses a portable, non-invasive device for providing therapeutic treatment to a knee joint comprising a knee cuff which in turn comprises a thermal exchange component for applying thermal therapy, a signal generator for generating a pulsed electromagnetic field (PEMF) in stimulators, and a controller for storing a treatment mode and communicating the treatment mode to the signal generator and stimulators. However, the orthotic device disclosed in Gill does not provide unloading support or strength to the knee joint and thus does not relieve pressure off the part of the knee joint that is affected by osteoarthritis, arthritides, or soft tissue pathologies. Further, no electrical stimulation is provided in order to alleviate the pain associated with the osteoarthritis.
U.S. Pat. No. 8,070,703 to Skahan et al. discloses a knee brace system comprising a substantially rigid brace structure having upper and lower supports for securing the brace to the patient's leg, liner segments attached to each support, and a plurality of electrodes attached to the liner segments which supply stimulation from an electrostimulation unit. Further, the liner segments can be removed and reattached to adjust their position in order to maintain stable contact between the electrodes and the patient's leg. Used in conjunction with the electrostimulation unit, the plurality of electrodes can provide an electrophysical modality, such as Surface Electrical Stimulation, NES, PEMF Stimulation, or TENS, to the patient's knee. However, Skahan does not provide for simultaneous or coordinated treatment of a combination of electrophysical modalities targeted at specific parts of the patient's knee, limb, and muscles.
While the prior art orthotic devices may provide benefits over conventional braces, they still suffer from several disadvantages. One of such disadvantages is that the orthotic devices do not provide multiple forms of pain management with a comprehensive therapeutic treatment of limb, joint or spine disorders involving the bones, cartilage, tendons, ligaments, muscles, nerves, and/or discs that suffer from arthritis or other damage. Another such disadvantage of the prior art is that they do not incorporate biofeedback monitoring and data to improve response to treatment. The prior art orthotic devices provide selective therapy and pain relief limited to a few bodily parts, such as only the muscles and joint. Consequently, such treatment allows for restoration of certain bodily parts while allowing continued deterioration of other bodily parts.